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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K854749
Device Name STARTANIUS DENTAL IMPLANT SYSTEM
Applicant
Park Dental Research Corp.
19 W. 34th St., Suite 301
New York,  NY  10001
Applicant Contact WIMMER
Correspondent
Park Dental Research Corp.
19 W. 34th St., Suite 301
New York,  NY  10001
Correspondent Contact WIMMER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/26/1985
Decision Date 03/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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